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Trial - TCTR20211102004


Column Value
Trial registration number TCTR20211102004
Full text link
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Karjbundid Surasit

Contact
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

offkarj1@hotmail.com

Registration date
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2021-11-02

Recruitment status
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Recruiting

Study design
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

single-center

Study aim
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Treatment

Inclusion criteria
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1. COVID-19 patients with age more than 15 year 2. Diagnosed as severe or critical COVID-19 infection 3. Already received favipirair or remdesivir in combination with corticosteroid (more than 6 mg of dexamethasone or equivalent dose) for more than 24-48 hours 4. Hyperinflammatory state including CRP &gt, 75 mg/L , ferritin &gt, 300 ng/ml and serum IL-6 level &gt, 20 pg/ml 5. Hypoxemia with PaO2 / FiO2 &lt, 300 and/or oxygen saturation room air &lt, 92 percent and/or Lung infiltration increasing more than 50 percent within 24-48 hours

Exclusion criteria
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1. Patients in terminal states (estimated no more than 24 hours alive) 2. Pregnancy 3. History of HA-330 catridge or Tocilizumab allergy 4. Recent myocardial infarction within 1 month 5. Persistent shock more than 12 hours 6. Patients who accepted DNR (do not resuscitation)

Number of arms
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2

Funding
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

N/A

Inclusion age min
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

15

Inclusion age max
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

100

Countries
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Thailand

Type of patients
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Severe/critical disease at enrollment

Severity scale
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

7: Severe/critical disease at enrollment

Total sample size
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

24

primary outcome
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

mortality 28 day 28 day mortality

Notes
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase 2

Arms
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "", "treatment_id": 566, "treatment_name": "Hemoperfusion", "treatment_type": "Non-pharmocologic agent", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]